Baxter MiniCap PD Transfer Set Recalled for Potential Chemical Exposure Risk
Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to polychlorinated biphenyls.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (chemical exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482. This product is used for peritoneal dialysis. The recall involves 4,380 units distributed worldwide, including nationwide in the US.
The recall is being conducted because Baxter is aware of recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal and hemodialysis devices. The source text does not specify if these chemicals were detected in this specific product, only that the risk is associated with the device category.
Patients and healthcare providers using this product should contact their healthcare provider or Baxter for instructions on what to do. The recall number is Z-0381-2025.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 4,380
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 04987456422890
- Lot/Serial Numbers: All lots including and manufactured after H20F09053
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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